Pulse Oximetry_Performance During Severe Signal Interference - PCBA-1 (Printed Circuit Board Assembly)

Controlled Acute Hypoxia Studies Comparing Pulse Oximetry to Arterial Blood Samples During Motion in Healthy, Well-perfused Subjects With the Functional Monitoring PCBA-1

Determine accuracy specifications and labeling claims of a pulse oximeter in a diverse subject population during severe signal interference over a specified saturation range.

Study Overview

• Status: Completed
• Conditions: Healthy

• Study Type: Observational
• Enrollment (Actual): 17

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Boulder, Colorado, United States, 80301
      • Covidien

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Healthy Well perfused

Description

Inclusion Criteria:

1. Male or female subjects between the ages of 18 to 50 years (inclusive).
2. Must undergo a physical examination by a licensed physician, advanced practice nurse or physician assistant, including a 12 lead ECG, a medical history, and a blood test checking complete blood count and screening for sickle cell trait or disease
3. All female volunteers must have a negative urine pregnancy test prior to participation.

Exclusion Criteria:

1. A room-air baseline % modulation < 1.5% on all four fingers on the test hand
2. Pregnancy or lactating women
3. History of syncopal episodes
4. Hypertension (defined as a systolic pressure of >145 mmHg or a diastolic pressure >90 mm Hg on three consecutive readings)
5. Premature ventricular contractions (PVC's) that are symptomatic or occur at a rate of more than 5/minute
6. History of seizures (except childhood febrile seizures) or epilepsy
7. Routine use of tranquilizers and/or excessive anxiety
8. History of frequent headaches or migraines
9. History of stroke
10. Previous injury or trauma to fingers or hands that may change blood flow or vascular supply and affect our ability to test multiple sensors
11. History of "altitude sickness" defined as headaches, malaise or dizziness when in the mountains or in an aircraft at altitude significantly above sea level for a prolonged period of time (> 1 hour)
12. History of significant respiratory disease, such as severe asthma, emphysema, etc.
13. Sickle cell disease or trait.
14. The use of medications, pre-existing medical conditions, treatment for a medical condition or any other reason deemed relevant by the clinician conducting the study.
15. A clinically significant abnormal finding on medical history, physical examination, clinical laboratory test or ECG. Clinical significance will be assessed by the principal investigator or designee.
16. Prior or known allergies to lidocaine (or similar pharmacologic agents, e.g., Novocain)
17. Prior or known allergies to heparin
18. History of transient ischemic attacks or carotid artery disease
19. History of myocardial ischemia, angina, myocardial infarction, congestive heart failure or cardiomyopathy
20. History of chronic renal impairment
21. History of recent arterial cannulation (less than 1 month prior to study)
22. History of complications from previous arterial cannulation
23. Current use of blood thinners

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
SpO2 Accuracy (percentage of blood oxygen saturation)	Duration of subject visit- approx. 1.5 hours

Collaborators and Investigators

• Sponsor: Medtronic - MITG

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: November 27, 2012
• First Submitted That Met QC Criteria: December 10, 2012
• First Posted (Estimate): December 11, 2012

Study Record Updates

• Last Update Posted (Estimate): December 6, 2013
• Last Update Submitted That Met QC Criteria: December 5, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Subjects
• Other Study ID Numbers: COVMOPR0384